Pharmaceutical agents and medicaments are commonly packaged and stored in storage containers under conditions to provide an extended shelf life. Liquid pharmaceutical agents and medicaments require storage contains that are sufficiently transparent to enable the user to visually inspect the product prior to use. Glass containers are commonly used to provide a non-reactive container to reduce degradation of the product and provide the necessary clarity for visual inspection.
Many pharmaceutical agents and medicaments are unstable or contain additives that diffuse into the wall of some containers which can result in degradation of the product. Glass ampules and containers generally provide a longer shelf life for liquid medications than containers made from polymeric materials. Polymeric containers are desirable from a manufacturing standpoint since they can be easily molded and are lightweight at low cost. Some pharmaceutical agents and medicaments are not suitable for long term storage in containers made from polymeric materials that can react with or adsorb/absorb components from the pharmaceutical agent or medicament.
Many pharmaceutical agents and medicaments require preservatives or stabilizing agents to improve the shelf life. One example is insulin which includes a preservative such as m-cresol, phenol, and/or mixtures thereof. The m-cresol and phenol can diffuse into many polymeric materials that are commonly used to make storage containers. The loss of the preservative from the insulin can result in the rapid degradation of the insulin during storage.
Various methods have been proposed for stabilizing pharmaceutical agents and medicaments for long term storage and producing storage containers and vessels that are able to provide long term storage. One example is disclosed in U.S. Pat. No. 5,945,187 to Buch-Rasmussen et al., which discloses a container for storing liquid medicaments. The medicaments include an active agent, water and a preservative. The liquid medicament can be insulin containing water and m-cresol, phenol and benzyl alcohol. The container is made from a crystalline polymer of linear or branched olefinic materials obtained from monomers of ethylene, propylene, butylene, or mixtures thereof and having a crystallinity above 35% by weight. The polymeric container is disclosed as providing a barrier against m-cresol, phenol, benzyl alcohol and water.
U.S. Pat. No. 7,029,752 to Hama et al. discloses a plastic container for a liquid medicine to prevent mixing with oxygen and water. The plastic container is made of a plastic material coated with a diamond-like carbon film having a water vapor permeability of 0-0.006 g/container/day and an oxygen permeability of 0-0.011 ml/container/day. The properties are obtained by optimizing the composition, density and film thickness of the diamond-like carbon film.
Many delivery devices such as prefilled syringes, infusion sets and infusion containers have been proposed which have generally been suitable for their intended use. These devices often require a separate storage vessel or ampule to prevent extended contact with the components of the delivery device that can result in degradation of the medicament by extended contact. Therefore, there is a continuing need for improved materials for delivery devices that provide improved storage properties of the medicament.